The Recall Desk

FDA (Devices) recall action 82313

Philips North America, LLC recalled 5 products on 2019-04-03

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2019-04-03
Critical
0
Units
9,572

Why these products were recalled

The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • SevereFDA (Devices)··2019-04-03

    Philips UroDiagnost MRF Recall Due to Missing Locking Plate

    Philips is recalling UroDiagnost MRF units because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cyst
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    0 states
  • HighFDA (Devices)··2019-04-03

    Philips MultiDiagnost-Eleva Imaging System Recalled for Missing Locking Plate

    Philips is recalling MultiDiagnost-Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This
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    0 states
  • HighFDA (Devices)··2019-04-03

    Philips MultiDiagnost Eleva Imaging System Recalled for Missing Locking Plate

    Philips is recalling MultiDiagnost Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications
    Category
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    0 states
  • HighFDA (Devices)··2019-04-03

    Philips OmniDiagnost X-ray System Recalled for Missing Locking Plate

    Philips North America is recalling 1,696 OmniDiagnost Classic X-ray systems because a missing locking plate may cause unexpected stand or table movement that users cannot stop.

    Product
    Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include:
    Category
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    0 states
  • HighFDA (Devices)··2019-04-03

    Philips URODiagnost Eleva X-ray System Recalled for Missing Locking Plate

    Philips North America, LLC is recalling URODiagnost Eleva X-ray systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-in
    Category
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    0 states